Document Management White Papers

Read a Document Management White Paper on How to Automate Document Management Processes to Comply with FDA Regulations and ISO Standards

Click on the document management white papers that we offer below (Automated Document Control Processes) the importance of an automated document management and document control system to FDA-regulated and ISO-compliant companies. Unfortunately, many companies continue to rely on paper-based and partially electronic document control systems that are plagued by inefficiency and errors that frequently are responsible for FDA-483 citations or ISO nonconformance which are also discussed in MasterControl's document management white papers.

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Infographic:

9 Pitfalls to Avoid During the Document Control Process

White Paper:

Automating Document Control Processes
Reducing the Documentation Burden in FDA Design Control
How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market
Top Five Ways Automation Can Boost Financial Success in the Life Sciences Industries

Product Data Sheet:

MasterControl Documents™
MasterControl Collaboration™

Toolkit:

9 Free Resources to Boost Your Document Control System

Demo Video:

MasterControl Quality Management System (QMS) Overview

As the document management white papers show, converting a paper-based document management process to an electronic process helps eliminate common errors that could lead to serious regulatory problems.

How can MasterControl's Document Management White Papers Benefit You?

MasterControl Documents, an integrated part of the MasterControl quality management suite, meets all requirements addressed in the document management white papers that we offer above. MasterControl Documents automates electronic document management processes in an efficient and cost-effective manner. Other critical requirements addressed by the document management white papers that MasterControl meets are identified below:

Revision Control: MasterControl provides automatic document revision control to ensure that only the current version of a standard operating procedure SOP is available. This ensures that companies never run the risk of executing processes based on out-dated version of any document. Whenever an edit is made to a document, the user is also prompted to enter the reason for the change. The software tracks all the changes made to the documents so that the process of reviewing and approving documents is simplified.

Solid Audit Trail: Many companies want to excel in business which is why it is very important to adhere to FDA and other global regulations. As explained in the document management white papers, the MasterControl solution equips companies with a secure, time-stamped audit trail exceeding 21 CFR Part 11 requirements. MasterControl's electronic signature feature helps in keeping track of the identity of any user who creates or modifies an electronic record, when the action occurred, and the changes made.

Security: Leakage of any important business information can cause severe loss of revenue for the company.21 CFR Part 11 emphasizes security practices that limit access to authorized users. With MasterControl, you can be assured of securing all company data away from competitors. Any electronic document is stored in virtual vaults located in a central database for access by authorized users only. The software automatically locks both login and approval anytime either one is compromised.

Advanced Tracking: MasterControl's electronic document management module is built to facilitate users in faster reviewing and approval of documents. Users can track documents by status or history. If tracked by status, a document will show as either "in process" or "complete." The revision or approval history of electronic documents can also be reviewed using the history feature.

Analytics and Reporting: In order to manage business in a controlled environment, top level management makes important decisions the on basis of several factors. It is imperative to derive parameters that accurately state the condition of the business. MasterControl's electronic document management system uses advanced analytics and reporting capabilities in the form of standard and customized reports to help increase management oversight.

Electronic Sign-offs: During several rounds of edits and reviewing, it becomes important to back track the document and find out how many users have made changes. With MasterControl, electronic documents can be signed and approved in an automated fashion. Electronic signature manifestation -- name, date, time, and meaning of electronic signature -- can be appended automatically to each document in the document management system.

Manage Different Document Types: As explained in the document management white papers, employees are encouraged to build documents and freely elaborate ideas through any software. MasterControl's electronic document management system helps employees to use any kind of software for documentation as it can manage different documents-based processes and handle all types of electronic documents regardless of the software used to create them.

Easy Access: One of the basic factors for any company is to provide easy access to employees so that documents are available without any hassle. MasterControl's document management system is web-based so they can connect all employees involved in document and quality control from virtually anywhere. The centralized repository for easy access, search, and retrieval of electronic documents by all authorized users helps in collaboration with users and processes.

Automates Routing, Escalation, Approval: In order to make the most recent version of documents readily available for users, companies want to speed up the time it takes to update, review and approve the standard operating procedures. MasterControl’s electronic document management system reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks.

Dependent Routing: Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task. This helps in bringing control and efficiency in the system.

Streamlines Collaboration: Creating and revising documents as a team is easier because MasterControl's document management system provide a collaboration workspace that allows a user to see other people's input. On the same lines, once a user is working on any document, the other users cannot view or alter the document. This helps in avoiding duplication and issues with version control.

Integrates with Other Applications: As the document management white papers explain, most business operations are dependent on several processes in the system. This calls out for the need of seamless integration between different applications to bring culmination of business operations. MasterControl's electronic document management system can integrate with other applications such as accounting, human resources, ERP, and LIMS applications to accommodate departmental needs.

Pre-Defined Workflow: Majority of the tasks in a company are delayed because they are not escalated on a timely basis. This causes inefficiency and waste of valuable resources for the company. Company-wide policies, SOPs, and other electronic documents that require inter-departmental collaboration move along a pre-defined workflow, from one department to the next are saved in the document management system for review. Overdue tasks automatically escalate to a manager.

Automation of Forms-Based Processes: Form processes unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be integrated with document-based processes under one secure repository. For example, an internal survey conducted by the HR department requires input from the employees.

Easy to Search: Companies with multiple processes have a huge pile of documents in the system. It becomes very important to have a quick search in the portal that helps in easily retrieving the documents without any delay. A standardized "Google-like" search window is available throughout the application, which means all authorized users throughout the organization can search for tasks, training records, policies, and other documents using a familiar search interface in MasterControl's document management system.

In addition, MasterControl's document management white papers explain how our Explorer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Explorers and documents can be stored in multiple Explorers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

For More Information on Document Management White Papers

For more information about the items discussed in the document management white papers that you can access above, please feel free to contact a MasterControl representative.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.